Xanax alprazolam
Refer to the “Also Known As” section to reference different products that include the same medication as Xanax.
Drug Basics
Brand Name: Xanax
Generic Name: ALPRAZOLAM
Drug Type: HUMAN PRESCRIPTION DRUG
Route: ORAL
Dosage Form: TABLET
Packager: Pharmacia & Upjohn Company LLC
Data Current As Of: 2021-03-29
Boxed Warning | 2/2021 |
Dosage and Administration (2.3) | 2/2021 |
Warnings and Precautions (5.2, 5.3) | 2/2021 |
Indications & Usage
XANAX is indicated for the:
- acute treatment of generalized anxiety disorder (GAD) in adults.
- treatment of panic disorder (PD), with or without agoraphobia in adults.
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Risks from Concomitant Use with Opioids
Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when XANAX is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined [see Warnings and Precautions (5.1), Drug Interactions (7.1)].
Abuse, Misuse, and Addiction
Inform patients that the use of XANAX, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions (5.2), Drug Abuse and Dependence (9.2)].
Withdrawal Reactions
Inform patients that the continued use of XANAX may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of XANAX may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of XANAX may require a slow taper [see Warnings and Precautions (5.3), Drug Abuse and Dependence (9.3)].
Effects on Driving and Operating Machinery
Advise patients not to drive a motor vehicle or operate heavy machinery while taking XANAX due to its CNS depressant effects. Also advise patients to avoid use of alcohol or other CNS depressants while taking XANAX [see Warnings and Precautions (5.3)].
Patients with Depression
Advise patients, their families, and caregivers to look for signs of suicidality or worsening depression, and to inform the patient's healthcare provider immediately [see Warnings and Precautions (5.6)].
Concomitant Medications
Advise patients to inform their healthcare provider of all medicines they take, including prescription and nonprescription medications, vitamins and herbal supplements [see Drug Interactions (7)].
Pregnancy
Benzodiazepines cross the placenta and may produce respiratory depression and sedation in neonates. Advise mothers using XANAX to monitor neonates for signs of sedation, respiratory depression, withdrawal symptoms, and feeding problems. Instruct patients to inform their healthcare provider if they are pregnant or intend to become pregnant during treatment with XANAX [see Warnings and Precautions (5.4) . Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to XANAX during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Advise women not to breastfeed during treatment with XANAX [see Use in Specific Populations (8.2)].
This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.
LAB-0004-12.0
MEDICATION GUIDE XANAX (ZAN-aks) (alprazolam) tablets, C-IV |
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This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: 3/2021 |
What is the most important information I should know about XANAX?
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What is XANAX?
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Do not take XANAX if:
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Before you take XANAX, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
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How should I take XANAX?
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What are the possible side effects of XANAX? XANAX may cause serious side effects, including:
The most common side effects of XANAX include:
These are not all the possible side effects of XANAX. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store XANAX?
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General information about the safe and effective use of XANAX.
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What are the ingredients in XANAX? Active ingredient: alprazolam Inactive ingredients: Cellulose, corn starch, docusate sodium, lactose, magnesium stearate, silicon dioxide and sodium benzoate. In addition, the 0.5 mg tablet contains FD&C Yellow No. 6 and the 1 mg tablet contains FD&C Blue No. 2. XANAX® is a registered trademark of Pharmacia & Upjohn Company LLC. For more information, go to www.pfizer.com or call 1-800-438-1985. |
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LAB 0825-3.0 |
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